NCT07851064

Brief Summary

Objectives: Although constipation can occur at any age, it is a common and treatable health problem among older adults. This randomized controlled study aimed to investigate the effect of abdominal massage on constipation among older adults receiving care services in a care center. Methods: The study included 86 older adults who met the Rome IV diagnostic criteria for constipation and had no contraindication to abdominal massage. Participants were randomly assigned equally to intervention and control groups using simple randomization. Abdominal massage was administered to the intervention group for 15 minutes per day, five days a week, for four weeks, while no intervention was applied to the control group. Constipation severity and constipation related quality of life were assessed using the Constipation Severity Scale (CSS) and the Patient Assessment of Constipation Quality of Life (PAC-QOL). Conclusions: Abdominal massage may be a non-invasive, low-cost, and easily applicable intervention for managing constipation among older adults. Further randomized controlled trials with longer intervention and follow-up periods are warranted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 18, 2026

Last Update Submit

September 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient Assessment of Constipation Quality of Life

    The Patient Assessment of Constipation Quality of Life (PAC-QOL) is a validated questionnaire designed to assess the impact of constipation and its symptoms on patients' quality of life. It evaluates four domains: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Higher scores indicate a greater negative impact of constipation on quality of life.

    At baseline and at the end of the 4-week intervention period

  • Constipation Severity Scale

    The Constipation Severity Scale (CSS) is a validated self-report instrument used to assess the severity of constipation symptoms. It evaluates three domains: obstructive defecation, colonic inertia, and pain. Higher scores indicate greater constipation severity. The CSS is commonly used to assess changes in constipation symptoms and treatment outcomes.

    At baseline and at the end of the 4-week intervention period

Study Arms (2)

Control

NO INTERVENTION

Control Group, Participants did not receive abdominal massage or any additional intervention during the study period.

Abdominal Massage

EXPERIMENTAL

Abdominal Massage Group, Participants received abdominal massage for 15 minutes per day, 5 days per week, for 4 weeks

Behavioral: Abdominal Massage

Interventions

Abdominal massage was administered for 15 minutes per day, 5 days per week, for 4 consecutive weeks. The intervention was provided to older adults receiving care services and was performed according to a standardized abdominal massage procedure. The control group did not receive abdominal massage or any additional intervention during the study period.

Abdominal Massage

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years or older. Presence of functional constipation according to the Rome IV diagnostic criteria.
  • Ability to participate in the study and provide informed consent.

You may not qualify if:

  • Dementia or cognitive impairment that prevented participation in the study procedures.
  • Presence of a colostomy. Inability to defecate physiologically due to an underlying medical condition. Any contraindication to abdominal massage. Any condition that prevented participation in the abdominal massage intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Candan Nursing Home and Elderly Care Center and the Private Candan Disabled Care Center in Aydın

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of two parallel groups: an abdominal massage intervention group or a control group. The intervention group received abdominal massage for 15 minutes per day, 5 days per week, for 4 weeks, while the control group received no abdominal massage or additional intervention during the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD in Geriatrics

Study Record Dates

First Submitted

September 18, 2026

First Posted

October 1, 2026

Study Start

January 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 30, 2024

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers because the data contain potentially identifiable participant information and are subject to ethical and privacy considerations.

Locations